Israel reviews 90,000 genetic tests after BRCA 1 screening kit fault

Israel's Ministry of Health has disclosed a malfunction in a genetic carrier screening kit made by the company Gamidor, used to test for common mutations in the BRCA 1 gene. According to the ministry's media statement, it received a notification that the kit carried a risk of producing an incorrect negative result, known as a false negative, meaning a person who does carry a relevant mutation could have been told they do not.

After the case came to light and the nature of the fault was investigated, the results of everyone tested with the affected kit were reviewed. The ministry says more than 90,000 tests were checked, and that Gamidor, working with genetic institutes and laboratories, identified 100 samples where a negative result may be incorrect. The ministry states that Gamidor has corrected the malfunction.

What happens next for those affected

The ministry says that in the coming days the genetic institutes and laboratories that ran the test using the faulty kit will contact the people concerned and, where necessary, invite them to give an additional blood sample. Because those whose results may be wrong are being approached directly, the ministry says there is no need for everyone who took the test to call the laboratory or genetic institute where it was performed. It adds that further updates will be issued as needed.

What the BRCA 1 test is for

BRCA 1 is a gene in which certain inherited changes, referred to in the ministry's statement as common mutations, are associated with hereditary cancer risk. Carrier screening for these changes is a routine part of Israeli medical genetics practice, and testing is widely used because particular BRCA mutations occur at elevated frequency in some Jewish populations, notably among Ashkenazi Jews. The ministry describes the test in question as a nanochip test, a laboratory platform designed to detect a defined set of known genetic changes rather than to sequence the whole gene.

That design matters for understanding the risk the ministry has described. A screening test that looks for a fixed panel of mutations gives a negative result meaning that none of the specific changes in the panel was detected. If the kit itself does not reliably detect one of those changes, the resulting negative can be wrong, which is precisely the false negative risk the ministry has flagged. The statement does not say which mutation or mutations were involved, or how the fault arose in the manufacturing or testing process.

Who issued the notice

The Ministry of Health, known in Hebrew as Misrad HaBriut, regulates medical devices and diagnostic products in Israel alongside its responsibilities for the public health system. Its statements on device malfunctions are published through the Executive Division for Public Information and Spokesperson Affairs, the government unit that issues official announcements. The notice was published under the ministry's medical genetics topic area and carries a publication date of 08.09.2026 with an update logged the following day, 09.09.2026.

Gamidor is named in the statement as the supplier of the kit and as the party that corrected the fault. The ministry credits the company, together with the genetic institutes and laboratories that carried out the tests, with identifying the samples at risk. The statement does not describe any regulatory action against the company, nor does it say whether the kit remains in use following the correction.

Why the review was so large

The gap between the number of tests reviewed, more than 90,000, and the number of samples flagged, 100, reflects the way such investigations are conducted: once a fault is identified, laboratories go back through the full body of results produced with the affected product and then narrow the search to the cases where the specific defect could have changed the outcome. The ministry does not explain the criteria used to reduce the review to the 100 samples, and it does not say over what period the affected kit was in use.

What the statement does not say

Several basic questions are left open. The ministry does not say when the malfunction began, how long the faulty kit was in circulation, or who notified the ministry of the problem. It does not identify the genetic institutes or laboratories involved, or how many facilities used the affected kit. There is no information on whether any of the 100 people whose results may be incorrect have already been retested, or whether any medical consequences have been identified.

The statement also does not describe the technical nature of the defect beyond the risk of a false negative, and it gives no detail on what corrective step Gamidor took. No comment from the company appears in the notice. The ministry notes that where the information on its page differs from the law, the provisions of the law apply, and says it will publish further updates as required. This account rests on that single official statement; no independent confirmation of the figures is available.